Singapore HSA registration DE0509831
Technoclone Ak-Calibrant
Singapore·CLASS C IVD·Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH·Registered September 24, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0509831
- Registration Date
- September 24, 2024
- Retention Due Date
- September 23, 2025
Product description
The AK calibration set can be used for the following purposes: For direct INR determination of a patient sample (INR reference curve). For establishing laboratory, instrument and reagent specific ISI and PT normal plasma values. For constructing a reference curve in percentage of the normal.
Product Owner
- Short Name
- Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
- Address
- Brunner Str. 67, 1230 Vienna, AUSTRIA
Registrant
- Address
- 6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Importer
- Address
- 6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model information
- Model Name(s)
- Ak-Calibrant
- Model Identifier(s)
- 5010004
About this record
Access comprehensive regulatory information for Technoclone Ak-Calibrant in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509831 and owned by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH. The device was registered on September 24, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD